Boston Scientific · 1 day ago
Senior Design Quality Engineer
US-MN-Maple Grove
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $170K/yr
5+ years expBoston Scientific is a leader in medical science, committed to solving health industry challenges. The Senior Design Quality Engineer will act as a Subject Matter Expert for Design Controls and Risk Management, focusing on product development and quality initiatives within acquisitions.
Health CareMedicalMedical Device
No H1B
Responsibilities
Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required
Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required
Applies technical quality engineering principles and systematic problem-solving methodologies to acquisition products or sites
Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management
Demonstrated competency in design activities to support the development of products to meet or exceed internal and external requirements
Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
Maintains and enhances cross-functional team relationships within divisions, manufacturing plants, distribution centers, and global BSC network
Advises management on potential improvements or enhancement to quality systems and processes in the company
Assists in identifying and developing tools that facilitate BEST4 processes
Qualification
Required
Bachelor's degree in Science, Health, or Engineering
Minimum of 5 years of related work experience in the medical device regulated industry
Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485, ISO 14971, EUMDR, CMDR, and MDSAP
High energy problem solver capable of driving items to closure
Strong presentation & communication skills
Computer skills required including Excel, Word, and PowerPoint
Potential global and US travel up to 40%
Preferred
> 3 years of experience working on acquisitions
> 3 years working with Active Implantable devices
> 3 years working with Capital Equipment
Experience within BSC quality systems
Project Management Experience
Experience working with functions such as Operations, Regulatory, Research and Development, Clinical, and Quality
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.01B2025-02-21Post Ipo Debt· $1.57B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
WSJ.com: US Business
2026-02-05
2026-02-05
2026-02-05
Company data provided by crunchbase